Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis (POISE)
A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
Sponsor: Intercept Pharmaceuticals
Listed as NCT01473524, this PHASE3 trial focuses on Primary Biliary Cirrhosis and remains completed. Sponsored by Intercept Pharmaceuticals, it has been updated 11 times since 2012, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)The study included 2 phases: a 12-month randomized, double-blind (DB), placebo-controlled, parallel group phase, followed by a long-term safety extension (LTSE) phase up to 5 years. Participants from the 12-month DB phase, including those who received placebo, were eligible to participate in the open-label LTSE phase. The Month 12 visit from the DB phase served as the Day 1 visit of the LTSE phase. After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA.
Data for the LTSE phase is reported by the randomized dose group assigned in the DB phase.
The study included 2 phases: a 12-month randomized, double-blind (DB), placebo-controlled, parallel group phase, followed by a long-term safety extension (LTSE) phase up to 5 years. Participants from the 12-month DB phase, including those who received placebo, were eligible to participate in the open-label LTSE phase. The Month 12 visit from the DB phase served as the Day 1 visit of the LTSE phase. After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA.
Data for the LTSE phase is reported by the randomized dose group assigned in the DB phase.
Status Flow
Change History
11 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jun 2021 — Jul 2024 [monthly]
Completed PHASE3
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Jan 2021 — Jun 2021 [monthly]
Completed PHASE3
▶ Show 6 earlier versions
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Nov 2020 — Jan 2021 [monthly]
Completed PHASE3
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May 2019 — Nov 2020 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Jun 2018 — May 2019 [monthly]
Active Not Recruiting PHASE3
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Jul 2017 — Jun 2018 [monthly]
Active Not Recruiting PHASE3
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Feb 2017 — Jul 2017 [monthly]
Active Not Recruiting PHASE3
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Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE3
First recorded
Jan 2012
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Intercept Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .